Packaged satiety enhancing composition

ABSTRACT

Compositions for enhancing satiety and weight loss in an individual, assays for assessing a tastant for enhancing satiety and weight loss, and methods of using the composition to suppress appetite and enhance weight loss are provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.10/306,198, filed Aug. 7, 2003, which claims the benefit of U.S.Provisional Application Ser. No. 60/334,401, filed Nov. 30, 2001.

FIELD OF THE INVENTION

The present invention relates generally to appetite suppression andweight loss, and more particularly to a composition that enhancessatiety during a meal and methods of using the composition to achievebody weight loss.

BACKGROUND OF THE INVENTION

With a third to a quarter of the American population overweight, obesityis rampant in contemporary society. At any given time, 40% of women and24% of men are trying to lose weight and of these, 84% of women and76-78% of men are dieting for this purpose. In the USA, losing weighthas become a national obsession. Over 30 billion dollars are spent eachyear devising a plethora of new diets and methods for losing weight,none of which have been demonstrated to be effective over a long term (2years).

Obesity is one of the most pervasive health problems in our society. Thephysical and psychological consequences have an impact on the afflictedin countless ways.

Almost all overweight people suffer derision and ridicule, but the worstprejudice is reserved for and directed towards obese women. We need onlylook at television commentators, politicians, and other public life torealize that overweight men do not experience the same degree ofdiscrimination that obese women suffer.

States of hunger and satiety are known to be of crucial importance inthe regulation of weight, and the perception of hunger is multivariate;environmental stimuli, psychological substrate, and internal physiologyall contribute a share. Everyday experiences attest to the influence ofambient aromas on our appetites; we salivate at the smell of freshlybaked cookies and feel nauseated at a whiff of sewer gas. When we arehungry, foods smell better and therefore, taste better. Conversely,olfactory ability wanes when we are satiated, lessening the hedonics offurther ingestion.

Anatomic connections of the olfactory bulb to the ventromedial nucleusof the hypothalamus, the satiety center, authenticate theseobservations, as does the presence of cholecystokinin, a gastic satietyfactor, as a neurotransmitter in the olfactory bulb. The fact thatpatients with acute anosmia often gain weight suggests that a failure ofthe olfactory-satiety feedback mechanism may be involved.

In a study to assess the effect on inhalation of certain aromas uponweight control, overweight subjects were given an inhaler containing ablend of odorants and instructed to inhale three times in each nostrilwhenever feeling hungry. New inhalers containing a new blend of odorantswere supplied each month over a period of six months. Data indicatedthat those subjects with normal olfactory abilities and who inhaledcertain odorants, used their inhalers frequently, ate two to four mealsa day, felt bad about overeating but not about themselves, lost nearlyfive pounds or two percent of body weight per month over the six-monthperiod.

This procedure has several drawbacks including the need andinconvenience of using an inhaler prior to a meal to inhale theodorants, the conspicuous nature of the inhaler, and the need to carrythe inhaler around.

Therefore, it would be desirable to provide a more effective andconvenient appetite suppression technique.

SUMMARY OF THE INVENTION

The present invention relates to a composition for enhancing satiety,assays for assessing a tastant for enhancing satiety, and methods ofusing the composition to suppress appetite.

The invention is based, in part, on the discovery of a specific role fortastant substances in appetite suppression and body weight loss.

In one aspect, the invention provides a satiety enhancing composition.The composition comprises a tastant, which when applied to or admixedwith food, is effective to enhance satiety (i.e., feeling of fullness),resulting in reduced food (caloric) intake during the meal. The satietyenhancing composition is preferably a dry, free-flowing powder form thatcan be sprinkled onto a foodstuff to be consumed. In one embodiment, thesatiety enhancing composition comprises a primarily sweet tastant. Inanother embodiment, the composition comprises a primarily salty tastant.The tastant type is preferably used in conjunction with foodstuffs mostappropriate to that taste type.

In another embodiment, the satiety enhancing composition comprises anamount of at least one tastant in combination with a carrier, andoptionally with an anti-caking agent, a coloring agent, or both, whichamount is effective to effect an average weight loss of about 0.5 lb. ormore per month over an about 6-month period, when the composition isapplied to and ingested with a foodstuff on a daily basis over the about6-month period.

In another aspect, the invention may provide a method of enhancingsatiety and suppressing appetite. In one embodiment, the methodcomprises applying a satiety enhancing composition to a foodstuff, thecomposition comprising an amount of a tastant which, when applied to afoodstuff and ingested, is effective to reduce caloric intake during ameal; and administering the food to a person for ingestion. In anotherembodiment, the method comprises selecting a satiety enhancingcomposition comprising a tastant; applying the satiety enhancingcomposition to a foodstuff; and administering the foodstuff to anindividual for ingestion. In yet another embodiment, a method forcontrolling appetite in an individual includes selecting a tastant basedon a foodstuff to be ingested and effectiveness of the tastant toenhance satiety; preparing a satiety enhancing composition comprising anamount of the tastant effective to reduce appetite when applied to andingested with a foodstuff; applying an effective amount of the satietyenhancing composition to the foodstuff; and administering the foodstuffto a subject for ingestion, wherein the intake of food by the subject isreduced.

In another embodiment, a method for promoting weight loss in a personinvolves applying a satiety enhancing composition to a food to beingested, the amount of tastant in the composition effective to cause areduction in the intake of food by the person; and administering thefood to the person for ingestion. The effect of the satiety enhancingcomposition can be measured, for example, by a reduction in body weightover a set time period, for example a 1-month period. Preferably, theapplication of the satiety enhancing composition to foodstuffs on adaily basis will effect a body weight loss of at least about 0.5 pound(lb.) per month, preferably at least about 1 lb. per month, preferablyat least about 3 lbs. per month, to up to about 5 lbs. per month,preferably up to about 10 lbs. per month, preferably up to about 15 lbs.per month, and preferably about 5 lbs. to up to about 20 lbs. over aninitial 6-month period, preferably up to about 25 lbs., preferably up toabout 35 lbs.

In yet another embodiment, a method of promoting weight loss accordingto the invention involves combining an effective amount of a satietyenhancing composition with substantially each food portion to beconsumed, on a daily basis over a one-month period, the compositioncomprising either a primarily sweet tastant or a primarily salty tastantas appropriate to the food type, and preferably, the same two tastantcompositions being used over the month period, to effect a monthlyweight loss of at least about 0.5 lb. to up to about 15 lbs. and,optionally, continuing such application of a satiety enhancingcomposition to substantially each food portion to be consumed overconsecutive one-month periods for up to 6-months or longer to effect anabout 5 lb. to an about 35 lb. weight loss over an about 6-month period,wherein the two compositions (i.e., comprising a primarily salty tastantor primarily sweet tastant) utilized during a subsequent one-monthperiod comprise different tastants than the two compositions utilized inthe preceding one-month period.

In another aspect, the invention provides a foodstuff comprising a foodcombined with a satiety enhancing composition according to theinvention. In one embodiment, the foodstuff comprises an admixture of aprimarily sweet food, and an amount of a satiety enhancing compositioncomprising a primarily sweet tastant effective to enhance satiety and/orsuppress appetite resulting in reduced food intake upon ingestion of thefoodstuff. In another embodiment, the foodstuff comprises an admixtureof a primarily salty food and an effective amount of a satiety enhancingcomposition comprising an effective amount of a primarily salty tastant.

In yet another aspect, the invention provides a method for assayingtastants for a satiety enhancing effect and appetite suppression, orweight loss enhancing effect, when applied to or admixed with afoodstuff and ingested. In one embodiment, the assay method comprisesselecting a tastant; formulating a composition consisting essentially ofthe tastant, a carrier, and optionally an anti-caking agent, a coloringagent, or both; applying an amount of the composition to a foodstuff;administering the foodstuff to the individual for ingestion; andassessing the effectiveness of the composition to reduce caloric intakeduring meals as measured, for example, by a reduction in body weight.

In another embodiment, a method of assaying a tastant for effectingweight loss of an individual, comprises the steps of: selecting atastant based on a food to be ingested, the tastant selected from thegroup consisting of a primarily salty tastant or a primarily sweettastant; formulating a composition consisting essentially of thetastant, a carrier, and optionally an anti-caking agent, a coloringagent, or both; combining the composition with each food to be ingestedby an individual to form a foodstuff; wherein a composition comprising aprimarily salty tastant is combined with a primarily salty food, and acomposition comprising a primarily sweet tastant is combined with aprimarily sweet food; administering each of said foodstuffs to theindividual for ingestion; repeating the combining and administeringsteps on a daily basis for an at least one month period; and assessingthe effectiveness of the composition to effect weight loss according toa change in weight of the individual. A preferred tastant is one thateffects an average weight loss of about 0.5 lb. or more per month overan about 6-month period.

In another aspect, the invention provides an article of manufacture. Inone embodiment, the article of manufacture comprises a unit amount ofthe satiety enhancing composition according to the invention containedwithin a packaging material, optionally with instructions for the use ofthe composition to enhance weight loss, or enhance satiety or suppressappetite for a resultant body weight loss, for example.

DETAIL DESCRIPTION OF THE INVENTION

In the current application, the term “tastant” is generally understoodto include substances having a flavor quality (i.e., salty, sweet, sour,bitter) combined with an aromatic quality. All percentages are by weightbased on the total composition, unless otherwise indicated.

The satiety enhancing composition of the invention can be formulatedwith one or more “sweet” tastants that impart a sweet taste, or one ormore “salty” tastants that impart a salty or non-sweet taste. Examplesof sweet tastants that can be used to achieve the benefits of theinvention include almond (benzaldehyde), anise, carob, cinnamon, cocoa(natural cocoa nibs), malt, peanut (roasted), pecan, pistachio(natural), peppermint, spearmint, and fruit type tastants includingapple (natural apple), banana, fig, kiwi, orange (sweet orange peel)peach, raisin, raspberry and strawberry, and the like, and mixtures orblends thereof. Examples of salty tastants that can be utilizedaccording to the invention include artichoke, asparagus, avocado, basil,broccoli, celery seed, cucumber, fennel, garlic, horseradish, mushroom,mustard (seed), onion, parmesan, pizza, ranch, spinach, taco, whitecheese (e.g., Romano), yellow cheese (e.g., cheddar), and the like, andmixtures or blends thereof.

The tastant can be a naturally-derived material or syntheticallyproduced, according to methods known and used in the art. The tastantcan be derived from concentrating the flavor components (extracts) ofnaturally occurring plants and herbs, and parts thereof. For example,the tastant can be extracted with a solvent (e.g., an alcohol/watermixture), and the extractant dried by spray drying or evaporation. Thetastant can comprise a blend of natural or synthetic flavors.

Examples of formulations for the composition include crystalline,microcrystalline, particles, granules, powder, spray-dried, lyophilized,and the like, forms that will admix with a foodstuff to which it isapplied, and dissolve or undergo disintegration or dissolution in thepresence of fluids in the mouth, stomach and/or intestine. Preferably,the composition is in the form of a free-flowing powder or granules, andcontains less than about 5 wt-% of moisture. The composition can also bein the form of an oil which is sprayed onto a carrier such as magnesiumcarbonate.

In a preferred form, the satiety enhancing composition is a powder orgranular mixture of the tastant and a suitable finely divided solid(powder, granules) base or carrier, which is odorless and tasteless,compatible with other ingredients of the formulation, and not harmful tothe recipient. Examples of such carriers include maltodextrin, dextrin,starch, methylcellulose, sodium carboxymethylcellulose, lactose, and thelike, with maltodextrin being preferred.

The composition can further include an anti-caking agent such astricalcium phosphate, and silicon dioxide (e.g., Flo-Gard AB silica),preferably in an amount of up to 2% by weight, based on the total weightof the composition. A compatible colorant and suitable for food (e.g.,FD&C dyes) such as FD&C Yellow #5 (Alum Lake 24-28%) and carmine (AlumLake based on carminic acid), can also be added, preferably in an amountof about 0.5% by weight or less, based on the total weight of thecomposition.

Other additives and adjuvants that can be included in the compositioninclude effective but minor amounts of preservatives such as ascorbicacid and sodium ascorbate; and anti-microbial agents such as sodiumbenzoate, potassium benzoate, potassium sorbate, parabens, and the like.

The satiety enhancing composition can be prepared by dry mixing a solidform (e.g., powder or granules) of the tastant with a finely dividedsolid carrier, and optional ingredients as desired. The components ofthe composition can be admixed as is known in the art and formulatedaccording to standard procedures. Preferably, each of the components ofthe composition is a FDA-GRAS approved food additive.

The satiety enhancing composition generally comprises the tastant in anamount of about 50% by weight up to about 99.98% by weight, based on thetotal weight of the composition. Typically, the tastant is included inan amount of about 50% to about 60% by weight, with the balance being acarrier and, optionally as desired, minor but effective amounts of ananti-caking agent and/or coloring agent. The amount of the tastant inthe composition depends, at least in part, on the form of the tastant,and the strength of the desired taste, and the hedonic quality of thetastant. The composition generally comprises 0 to up to 0.5% by weightcoloring agent, typically about 0.01% to about 0.03% by weight whenincluded, and 0 to up to about 2% by of an anti-caking agent, typicallyabout 0.5% to about 1% by weight when included, and about 40% to about50% by weight carrier, based on the total weight of the composition. Anexemplary satiety-enhancing composition comprises about 50% to about 60%by weight tastant (dry powder form), about 40% to about 50% by weightmaltodextrin (granulated), 0 to about 1% by weight tricalcium phosphate,and 0 to about 0.03% by weight colorant, based on the total weight ofthe composition.

The satiety enhancing composition can be conveniently provided indiscrete packaged amounts, for example, an amount to be used in a dailyintake of food, or over a 1-month period of time. For example, thecomposition can be packaged as a powder form in hard or soft gelatincapsules, cartridges, blister packages, envelopes, tubes, vials,ampoules, bottles, lidded cylinders, a shaker-type container with holesfor dispensing the composition, among other containers.

The amount of the tastant in a composition required for use in enhancingsatiety may be varied or adjusted according to the particularapplication, the potency of the tastant selected, and the taste andolfactory threshold of the individual. An amount of the compositionapplied to each portion of food to be ingested in a day is effective indiminishing appetite and enhancing satiation, resulting in reducedcalorie intake during the meal, as evidenced by body weight loss over aset time period. In general, a sufficient amount of the composition toprovide the benefits of the invention for an average adult human is inan amount of about 1/16 tsp. to about 1 tsp. or more, typically about1/16 tsp. up to about ½ tsp., per about 8 oz. of food (wet or dryweight), depending on the particular application. On average, an adultperson consumes up to about 20 meals or snacks per day, and thecomposition is preferably applied to each food portion that is eaten ona daily basis. The upper amount of the composition that is added to thea food portion is generally limited by the taste preference andtolerance of the individual.

In use, a satiety enhancing composition comprising a tastant mostappropriate to the taste type of the foodstuff (i.e., sweet or salty) isapplied to (e.g., sprinkled onto), and optionally admixed with, thefoodstuff, which is then consumed. Either a composition comprising aprimarily salty tastant or tastant blend or a composition comprising aprimarily sweet tastant or tastant blend can be used, depending onwhether the foodstuff to be consumed is classified as a primarily“sweet” food or “salty” (non-sweet) food. The satiety enhancingcomposition is applied to or admixed with the foodstuff in an amounteffective to extend the satiation effect of that foodstuff, and achieveappetite suppression and a reduction in caloric intake.

Examples of primarily “sweet” edible foodstuffs include sweet bakedgoods, cake, pudding, cookies, candy, pies, and the like. Examples ofprimarily “salty” edible foodstuffs include breads, baked goods, meats,poultry, seafood, stews, casseroles or baked dishes, potatoes,vegetables, cereal, potato chips, cheese curls, pretzels, crackers, andthe like.

The satiety enhancing composition taken orally with a foodstuff resultsin the individual being satiated with a lower caloric intake. Thesatiety enhancing composition can be used with a weight loss program ordiet to reduce appetite for food, and/or as a weight loss maintenancesystem. Preferably, the ingestion of the satiety enhancing compositionwith the foodstuff effectively suppresses food intake by about 10% toabout 30%, which can be demonstrated by an associated body weightreduction over a set time period, for example, a 1-month period or more,over which a weight loss of about 0.5 lb. to up to about 5 lbs. or moreper month can occur, preferably about 1 lb. to up to about 10 lbs. ormore per month, preferably about 3 lbs. to about 15 lbs. per month, andup to about 20 lbs. over a 6-month period, preferably up to about 25lbs., preferably up to about 35 lbs. over a 6-month period.

In a preferred use of the satiety enhancing composition to promoteweight loss, a set of two satiety enhancing compositions are utilizedcontinuously over a one-month period, the first comprising a primarilysweet tastant, and the second comprising a primary salty tastant, andapplied to each food item that is consumed on a daily basis over theone-month period. Preferably, the procedure is continued overconsecutive months, preferably up to at least about 6 months, utilizinga different set of two compositions containing a different sweet tastantor salty tastant than the preceding month. Preferably, such applicationof the compositions results in a body weight loss of at least about 0.5lb. per month, preferably at least about 1 lb. per month, preferably atleast about 3 lbs. per month, to up to about 5 lbs. per month,preferably up to about 10 lbs. per month, preferably up to about 15 lbs.per month, and about 5 lbs. to up to about 35 lbs. over an about 6-monthperiod. The same set of compositions is preferably utilized over anentire month period. As such, a tastant not traditionally used on aparticular foodstuff can be applied. For example, a peppermint tastantcan be combined with a breakfast cereal, or a horseradish tastant withpizza, etc.

The satiety enhancing composition can be provided as an article ofmanufacture comprising a unit amount of the composition contained withinthe packaging material, wherein the composition comprises a tastant orblend of tastants in an amount effective to enhance satiety or suppressappetite. The packaging material is preferably a water imperviousmaterial. Exemplary packaging materials include a box, cylinder,cartridge, vial, ampoule, container with openings (covered) fordispensing the composition (i.e., a shaker), bottle, tube, blisterpackage, envelope, hard or soft gelatin capsules, and the like. Thepackaging material includes instruction means that indicate that thesatiety enhancing composition can be mixed with food and consumed toenhance satiety or suppress appetite. Suitable instruction means includeprinted labels, printed package inserts, tags, cassette tapes, CDs,computer discs, and the like.

EXAMPLE 1

An open label study can be conducted as follows to assess the effect ofindividual tastants to induce body weight loss of an individualparticipant. An exemplary study group can include 15,000 adults based onthe following criteria.

Inclusion/Exclusion Criteria

Inclusion criteria can be as follows:

-   -   1. Beyond ideal weight and not obese (body mass index (BMI) less        than or equal to 30 kg m²) (Mokdad et al., The continuing        epidemics of obesity and diabetes in the United States, JAMA        286:1195-1200 (2001)).    -   2. Age 18-64    -   3. Likes to eat between meals    -   4. Does not exercise on a regular basis    -   5. Likes pickles or ice cream (separately)

Exclusion criteria can be as follows:

-   -   1. Pregnancy    -   2. Planning to become pregnant in the next 6 months.    -   3. Breast feeding    -   4. Perceived poor ability to taste    -   5. Uncontrolled hypertension, diabetes, or Sjorgren's syndrome

The following satiety enhancing composition can be formulated withtastants in the amounts indicated.

TABLE 1 Composition Tastant % by weight Natural Apple Flavor Blendnatural apple flavor (Sensient)) 60 Roasted Peanut Flavor natural andartificial peanut butter flavor, 60 Blend powder (Gold Coast) naturalpeanut flavor (Sensient) 2 Raspberry Burst Flavor natural and artificialraspberry flavor (Gold 50 Blend Coast) Blended Cinnamon Flavorartificial cinnamon flavor, powder (Flavor 50 Concepts) Pistachio FlavorBlend natural and artificial pistachio flavor (Sensient) 60 CoolSpearmint Flavor natural and artificial spearmint flavor (Gold 50 BlendCoast) Rich Cocoa Flavor Blend natural cocoa nibs flavor, powder (Carmi50 Flavor) Banana Shake Flavor Blend natural and artificial bananaflavor (Gold 50 Coast) Horseradish Kick Flavor natural horseradishpowder (SpiceTec-USF) 70 Blend Supreme Garlic Flavor natural garlicflavor (Sensient) 60 Blend Sharp Cheddar Cheese natural and artificialcheddar cheese flavor 60 Flavor Blend (Gold Coast) Romano Cheese Flavornatural and artificial Romano cheese flavor 60 Blend (Gold Coast) YellowOnion Flavor onion powder 99.975 Sharp Cheddar Cheese natural andartificial cheddar cheese flavor 50 (Gold Coast) Sweet Apple Flavornatural apple flavor powder WONF (Carmi 65 Flavor)

Methodology

A demographic questionnaire that documents, for example, age, race, sex,marital status, religion, employment status, alcohol consumption,smoking habits, drug usage, food preferences, eating habits, and soforth, can be completed by each participant.

Tastants and other ingredients of the tastant compositions arepreferably FDA/GRAS approved. Compositions comprising an individualtastant or blends of tastants can be packaged in individual containersand labeled as either “salty” or “sweet”, and coded such that theidentity of tastant (or blend) in the composition is not revealed to theparticipant.

Each month, a participant can be given a one-month supply of twodifferent satiety enhancing compositions, one containing a primarilysweet tastant (or blend thereof), and one containing a primary saltytastant (or blend thereof). The participant can be instructed to, eachday, sprinkle an amount of the composition on all food, similar to howshe/he would use salt or sugar, using a sweet tastant composition onprimarily sweet foods, and a salty tastant composition on primarilysalty foods. Participants can be told not to deviate from their usualdiet and exercise habits. Two new test compositions can be provided eachmonth for a period of 6 months. On initiation, subjects can completewritten questionnaires regarding height and weight, hedonics (i.e., foodpreferences), demographics, and outlook (self-perception). Theparticipants can be weighed monthly. Each month, two new tastantcompositions can be provided, a questionnaire on weight, hedonics andoutlook can be completed, and weight loss can be assessed as it relatesto the tastants being tested and hedonics for the tastants.

The particular tastant composition, and frequency of the use of thecompositions can be correlated with the amount of weight loss. Data canbe analyzed, for example, using Pearson Correlation coefficients and Itests. Data can also be analyzed using Signed Rank Test, Wilcoxin RankSum Test, and Spearman's Rank Correlation Coefficient (T. Colton,Statistics in Medicine, Little Brown & Co., Boston, Mass. (1974); E. L.Lehmann, Nonparametrics: Statistical Methods Based on Ranks, Holden-Day,New York, N.Y. (1975)).

The expected results are a reduction in body weight and increase inself-esteem for the participant. In addition, the effectiveness of thedifferent tastants that are tested can be assessed and rated.

EXAMPLE 2

An open label study was conducted according to the protocol described inExample 1.

The Test Group included 92 adults: 73 females (79%) and 19 males (21%).

The Control group included 100 adults: 75 females (75%) and 25 males(25%).

Demographics. Each of the participants initially filled out aquestionnaire regarding age, race, height, weight, amount of exerciseper day and food preferences. The participants weighed themselves, andtheir body mass index was determined.

For the Test Group participants, the age range was 18 to 64 years old,with an average of 48 years of age. Race was reported as 74 Caucasians(80%), 14 African Americans (15%), 2 Hispanic (2%), and 2 “Other” (2%).The average amount of exercise per day was 15 minutes. The weight of theparticipants ranged from 130 to 348 pounds, with the average initialweight being 197 pounds. The body mass index (BMI) of the participantsranged from 25 to 49, with the average being a BMI of 31.

For the Control Group participants, the average initial weight was 192lbs. and the average body mass index (BMI) was 30.

Protocol. Each of the Test Group participants were provided with twotastants compositions per month for a six month period, as shown belowin Table 2.

The Test Group participants were instructed to sprinkle an amount of thetastant composition on all food each day, similar to how she/he woulduse salt or sugar, using a sweet tastant composition on primarily sweetfoods, and a salty tastant composition on primarily salty foods. Theparticipants weighed themselves monthly, and completed a questionnaireon hedonics of the tastant compositions.

The Control Group participants did not ingest tastant compositions withtheir food over the monitoring period.

TABLE 2 (Test Group) Weight Change (lbs) Salty Sweet Average AverageMonth # Tastant Tastant Weight Change Range Initial — — 197 — — 1Cheddar Coca Flavor 193.7 −3.3 −7 to +5 Cheese Flavor 2 Onion FlavorSpearmint 191.2 −2.5 −11 to +3  Flavor 3 Horseradish Banana 191.1 −0.1−7 to +6 Flavor Flavor 4 Ranch Strawberry 190.8 −0.3  −5 to +12 FlavorFlavor 5 Taco Flavor Raspberry 191.4 +0.6 −6 to +9 Flavor 6 ParmesanMalt Flavor 191.4 −0.0 −1 to +1 Flavor Final 191.4 −5.6 (−2.8%) (−34 to+6) 

Results. The monthly average weight loss of the Test Group ranged from 0lbs. (month 6) to −3.3 lbs. (month 1). The overall 6-month averageweight change of the Test Group was a loss of −5.6 lbs., or an averageweight loss of about −3%.

By comparison, the overall 6-month average weight change of the ControlGroup was a gain of +1.1 lbs., or an average weight gain of +0.6%.

This indicates an average overall improvement in the Test Group of −6.7lbs. (from −5.6 lbs. to +1.1 lbs.).

The Test Group also had an average −2.8% change in body mass index (froman average BMI of 31 to 28.2), while the Control Group showedsubstantially no change.

Discussion. The results show that tastants (flavorants) may be used as away of inducing weight loss in those attempting to lose weight, and canbe integrated into a comprehensive weight loss program.

The invention has been described by reference to detailed examples andmethodologies. These examples are not meant to limit the scope of theinvention. It should be understood that variations and modifications maybe made while remaining within the spirit and scope of the invention,and the invention is not to be construed as limited to the specificembodiments disclosed. The disclosures of references cited in theapplication are incorporated by reference herein

1. An article of manufacture, comprising a unit amount of a satietyenhancing composition contained within a packaging material, the satietyenhancing composition comprising a tastant and a carrier, thecomposition being in the form of a free-flowing powder or granules thatcan be sprinkled onto a foodstuff, the packaging material includinginstructions to sprinkle the composition on the food to enhance satietyor suppress appetite, the unit amount of the satiety enhancingcomposition being a one-day or one-month supply of the composition whenused as instructed.
 2. The article of claim 1 wherein the carrier isselected from the group consisting of maltodextrin, dextrin, starch,methylcellulose, sodium carboxymethylcellulose, and lactose.
 3. Thearticle of claim 1 wherein the person is instructed to sprinkle acomposition comprising a tastant having a sweet flavor quality ontoprimarily sweet foods.
 4. The article of claim 1 wherein the person isinstructed to sprinkle a satiety enhancing composition comprising atastant having a salty flavor quality onto primarily salty foods.
 5. Thearticle of claim 3 wherein the tastant is a sweet tastant selected fromthe group consisting of almond (benzaldehyde), anise, carob, cinnamon,cocoa (natural cocoa nibs), malt, peanut (roasted), pecan, pistachio(natural), peppermint, spearmint, fruit tastants, and combinationsthereof.
 6. The article of claim 4 wherein the tastant is a saltytastant selected from the group consisting of artichoke, asparagus,avocado, basil, broccoli, celery seed, cucumber, fennel, garlic,horseradish, mushroom, mustard (seed), onion, parmesan, pizza, ranch,spinach, taco, white cheese, yellow cheese, and combinations thereof. 7.The article of claim 1 wherein the unit amount is a one-day supply whenused as instructed.
 8. The article of claim 1 wherein the unit amount isa one-month supply when used as instructed.
 9. The article of claim 2wherein the unit amount is a one-day supply when used as instructed. 10.The article of claim 2 wherein the unit amount is a one-month supplywhen used as instructed.
 11. The article of claim 3 wherein the unitamount is a one-day supply when used as instructed.
 12. The article ofclaim 3 wherein the unit amount is a one-month supply when used asinstructed.
 13. The article of claim 4 wherein the unit amount is aone-day supply when used as instructed.
 14. The article of claim 4wherein the unit amount is a one-month supply when used as instructed.15. The article of claim 5 wherein the unit amount is a one-day supplywhen used as instructed.
 16. The article of claim 5 wherein the unitamount is a one-month supply when used as instructed.
 17. The article ofclaim 6 wherein the unit amount is a one-day supply when used asinstructed.
 18. The article of claim 6 wherein the unit amount is aone-month supply when used as instructed.
 19. An article of manufacturecomprising a set of two individually packaged satiety enhancingcompositions, the article comprising a unit amount of each of the twocompositions, one of the compositions comprising a primarily sweettastant and a carrier, the other of the two compositions comprising aprimarily salty tastant and a carrier.
 20. The article of claim 19wherein each of the compositions is in the form of a free-flowing powderor granules.
 21. The article of claim 20 wherein the carrier is selectedfrom the group consisting of maltodextrin, dextrin, starch,methylcellulose, sodium carboxymethylcellulose, and lactose.
 22. Thearticle of claim 19 wherein the primarily sweet tastant is selected fromthe group consisting of almond (benzaldehyde), anise, carob, cinnamon,cocoa (natural cocoa nibs), malt, peanut (roasted), pecan, pistachio(natural), peppermint, spearmint, fruit tastants, and combinationsthereof.
 23. The article of claim 19 wherein the primarily salty tastantis selected from the group consisting of artichoke, asparagus, avocado,basil, broccoli, celery seed, cucumber, fennel, garlic, horseradish,mushroom, mustard (seed), onion, parmesan, pizza, ranch, spinach, taco,white cheese, yellow cheese, and combinations thereof.
 24. The articleof claim 20 wherein the primarily sweet tastant is selected from thegroup consisting of almond (benzaldehyde), anise, carob, cinnamon, cocoa(natural cocoa nibs), malt, peanut (roasted), pecan, pistachio(natural), peppermint, spearmint, fruit tastants, and combinationsthereof.
 25. The article of claim 20 wherein the primarily salty tastantis selected from the group consisting of artichoke, asparagus, avocado,basil, broccoli, celery seed, cucumber, fennel, garlic, horseradish,mushroom, mustard (seed), onion, parmesan, pizza, ranch, spinach, taco,white cheese, yellow cheese, and combinations thereof.
 26. The articleof claim 21 wherein the primarily sweet tastant is selected from thegroup consisting of almond (benzaldehyde), anise, carob, cinnamon, cocoa(natural cocoa nibs), malt, peanut (roasted), pecan, pistachio(natural), peppermint, spearmint, fruit tastants, and combinationsthereof.
 27. The article of claim 21 wherein the primarily salty tastantis selected from the group consisting of artichoke, asparagus, avocado,basil, broccoli, celery seed, cucumber, fennel, garlic, horseradish,mushroom, mustard (seed), onion, parmesan, pizza, ranch, spinach, taco,white cheese, yellow cheese, and combinations thereof